IGM Biosciences Initiates First-in-Human Clinical Trial of IGM-7354 in Solid Tumors

Rhea-AI Summary

IGM Biosciences announces the initiation of a Phase 1 clinical trial for IGM-7354, an IL-15/IL-15R IgM antibody targeting solid and hematologic malignancies. The trial aims to assess the safety, pharmacokinetics, and immune cell proliferation in patients with relapsed or refractory solid tumors. If successful, the company may advance to combination studies with T cell engaging antibodies and CAR-T cells as early as 2024. The development represents a significant milestone, focusing on enhancing immune activity in the tumor microenvironment while minimizing systemic toxicity. Collaboration with Sanofi is expected to drive further advancements.

Positive

• First patient dosed in Phase 1 trial for IGM-7354, indicating progression in clinical development.
• Potential for IGM-7354 to enhance immune response in tumor microenvironment, which could lead to effective cancer treatments.
• Plans for future combination studies with T cell engaging antibodies and CAR-T cells could broaden therapeutic applications.

Negative

• Clinical trial results could vary, leading to uncertainty in the efficacy of IGM-7354.
• Risks associated with a novel therapeutic approach and the potential for adverse effects during trials.
• Dependence on successful patient enrollment and manufacturing capabilities may pose challenges.

– Targeted IL-15/IL-15R IgM antibody to be evaluated for safety and pharmacodynamic effects –

MOUNTAIN VIEW, Calif., Jan. 17, 2023 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced that the first patient has been dosed in its Phase 1 clinical trial evaluating IGM-7354, a targeted IL-15/IL-15R IgM antibody which could potentially be used for the treatment of patients with solid and hematologic malignancies.

The multicenter, open-label, dose escalation Phase 1 clinical trial will evaluate IGM-7354 intravenously administered as a monotherapy in patients with relapsed and/or refractory solid tumor cancers. The key objectives of this trial are to provide an initial assessment of pharmacokinetics, safety and immune cell proliferation. If IGM-7354 shows an encouraging safety profile and significant increases in T cells and natural killer (NK) cells in this clinical trial, the Company may begin combination studies of IGM-7354 with T cell engaging antibodies in 2024. The Company may also decide to pursue combination studies with CAR-T or CAR-NK cells with a partner.   

“The initiation of this clinical trial is another significant milestone in IGM’s development, as it is the first clinical study of an IgM targeted immune cytokine,” said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. “If IGM-7354 shows an encouraging safety profile and significant increases in T cells and NK cells, we believe it may have clinical application in treating cancer in combination with a broad range of oncology drugs that rely on those immune cells for efficacy.”

About IGM-7354
IGM-7354 is a targeted IL-15/IL-15R IgM immune stimulating antibody for the treatment of patients with solid tumors and hematologic malignancies. The antibody binding domains of IGM-7354 target PD-L1 and are designed to concentrate the delivery of IL-15 in the area of cells with PD-L1 expression, including PD-L1-expressing tumors and tumor-draining lymph nodes. Through this targeting, IGM-7354 may be able to enhance the immune system’s activity in the tumor microenvironment, while potentially reducing systemic toxicities.

About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, infectious diseases and autoimmune and inflammatory diseases. The Company’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. The Company also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets. For more information, please visit www.igmbio.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements, including statements relating to IGM’s plans, expectations and forecasts and to future events. Such forward-looking statements include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including IGM-7354; and statements regarding the clinical development of IGM-7354, including plans for future combination studies involving IGM-7354. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: potential delays and disruption resulting from the COVID-19 pandemic and governmental responses to the pandemic; IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM’s ability to successfully and timely advance its product candidates through preclinical studies and clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM’s ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates, and the progress and success of alternative therapeutics currently available or in development; IGM’s ability to obtain additional capital to finance its operations, if needed; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; general economic and market conditions; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Quarterly Report on Form 10-Q filed with the SEC on November 3, 2022 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

Contact:

Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com

FAQ

What is the purpose of the Phase 1 clinical trial for IGM-7354?

The trial aims to evaluate the safety, pharmacokinetics, and immune cell proliferation of IGM-7354 in patients with relapsed or refractory solid tumors.

What are the expected outcomes if IGM-7354 shows a positive safety profile?

Should IGM-7354 demonstrate an encouraging safety profile, the company may initiate combination studies with other oncology drugs in 2024.

What does IGM-7354 target in cancer treatment?

IGM-7354 is designed to target IL-15/IL-15R, potentially enhancing immune activity specifically in areas with PD-L1 expression in tumors.

What are the potential risks associated with the IGM-7354 trial?

The trial faces risks such as variability in clinical trial results and potential adverse effects from the novel IgM antibody approach.

What is IGM Biosciences' collaboration with Sanofi?

IGM Biosciences has an exclusive worldwide collaboration agreement with Sanofi to develop and commercialize IgM antibody agonists targeting oncology and immunology.